Division 1 F1

In order to be given approval each embryo collection team shall comply with the following requirements:

1. 1.1.

   the collection, processing and storage of embryos shall be carried out either by a team veterinarian or under his responsibility by one or more technicians who are competent and trained by the team veterinarian in methods and techniques of hygiene and in techniques and principles of disease control;

2. 1.2.

   the team veterinarian shall be responsible for all team operations, including amongst others:

   1. (a)

      verification of the identity and health status of the donor animal;

   2. (b)

      sanitary handling and surgery of donor animals;

   3. (c)

      disinfection and hygienic procedures;

   4. (d)

      keeping records which shows:

      1. (i)

         the species, breed, date of birth and identification of each donor animal;

      2. (ii)

         the health history and all diagnostic tests and the results thereof, treatments and vaccinations carried out on donor animals;

      3. (iii)

         the place and date of collecting, processing and storing of oocytes, ova and embryos;

      4. (iv)

         the identification of embryos and details of their destination if known;

3. 1.3.

   the team shall be placed under the general supervision of the official veterinarian, who shall inspect it at least once every calendar year to ensure, where necessary based on records, standard operating procedures and internal audits, compliance with the sanitary conditions regarding collection, processing and storage of embryos and to verify all matters relating to the conditions of approval and supervision;

4. 1.4.

   the team shall have at its disposal a permanently sited laboratory or a mobile laboratory where embryos can be examined, processed and packed, consisting of at least a work surface, an optical or stereo microscope and cryogenic equipment where necessary;

5. 1.5.

   in the case of a permanently sited laboratory, it shall have:

   1. (a)

      a room where embryos can be processed which is physically separate from the area used to handle the donor animals during collection;

   2. (b)

      a room or area for cleansing and sterilising instruments, except when using only single-use equipment;

   3. (c)

      a room for storing embryos;

6. 1.6.

   in the case of a mobile laboratory, it shall:

   1. (a)

      have a specially equipped part of the vehicle consisting of two separate sections:

      1. (i)

         one for the examination and processing of embryos which shall be a clean section; and

      2. (ii)

         the other for accommodating equipment and materials used in contact with the donor animals;

   2. (b)

      use only single-use equipment, unless the sterilisation of its equipment and the provision of fluids and other products necessary for the collection and processing of embryos can be ensured by the contact with a permanently sited laboratory;

7. 1.7.

   the design and layout of buildings and laboratories shall be laid out and team operations carried out so as to ensure that cross-contaminations of embryos are prevented;

8. 1.8.

   the team shall have at its disposal storage premises which shall:

   1. (a)

      comprise at least one lockable room for the storage of ova and embryos;

   2. (b)

      be easy to cleanse and disinfect;

   3. (c)

      have permanent records of all incoming and outgoing ova or embryos;

   4. (d)

      have storage containers for ova and embryos which are stored in a place which is under the control of the team veterinarian and which is subject to regular inspections by an official veterinarian;

9. 1.9.

   the competent authority may authorise storage of semen in storage premises referred to in point 1.8 provided that the semen:

   1. (a)

      meets the requirements of this Directive for either ovine and caprine species or equine species, or of Council Directive 90/429/EEC of 26 June 1990 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the porcine species ^f1 for porcine species;

   2. (b)

      is stored for the operation of the team in separate storage containers in the premises for storing approved embryos.